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Disulfiram for Cocaine Abuse in Buprenorphine Treatment

Primary Purpose

Cocaine Dependence, Opioid Dependency

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Disulfiram

Placebo

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Disulfiram, Buprenorphine, Cocaine dependence, Opioid dependence, Dopamine-Beta-Hydroxylase

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

English speaking adults ages 18 - 45.
Meeting FDA criteria for agonist maintenance treatment and DSM-IV criteria for opioid dependence and cocaine dependence or abuse as assessed by SCID interview and documented by opioid positive and cocaine positive urine toxicology testing.
Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy testing during the course of the study.

Exclusion Criteria:

Current physiologic dependence on benzodiazepines or alcohol, unless first detoxified. Subjects who use/abuse alcohol will be included but will be cautioned about alcohol use during the study because of the possibility of an alcohol-disulfiram reaction.
Use of the antibiotic agents metronidazole or clotrimazole, which have disulfiram-like effects in combination with alcohol.
Presence of significant cardiovascular, renal, hepatic or neurologic illness. Subjects with markedly abnormal liver function tests (i.e., AST of ALT > 3X normal) will also be excluded.
Presence of any of the following cardiovascular risk factors:
- age > 45 years
- history of cocaine-related chest pain
- systolic blood pressure > 140 or diastolic blood pressure > 90
- evidence of ischemia or past myocardial infarction on EKG
- significant family history of risk (first degree relative with myocardial infarction prior to age 60)
- elevated cholesterol (> 300 mg/dl), elevated LDL (> 170 mg/dl) or low HDL (< 20 mg/dl)
Maintenance on methadone at doses greater than 30mg daily. Admittance to the study will only be offered to individuals who have been maintained on 30 mg of methadone or less daily for seven days prior to entering the study.
Current suicide or homicide risk or current psychotic disorder.
Inability to read or understand the symptom checklists.

Sites / Locations

The APT Foundation MRU
Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Disulfiram

Placebo

Arm Description

Disulfiram 250 mg per day

Placebo

Outcomes

Primary Outcome Measures

Cocaine abstinence

Secondary Outcome Measures

Opioid abstinence

Full Information

NCT ID

NCT00913484

First Posted

June 3, 2009

Last Updated

November 18, 2020

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00913484

Brief Title

Disulfiram for Cocaine Abuse in Buprenorphine Treatment

Official Title

Disulfiram for Cocaine Abuse in Buprenorphine Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

October 2000 (undefined)

Primary Completion Date

February 2004 (Actual)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary

The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.

Detailed Description

The Specific Aims and hypotheses for the proposed study are as follows: To compare the efficacy of disulfiram versus placebo for the treatment of buprenorphine maintained patients with concurrent opioid and cocaine dependence. Study hypothesis 1 is that disulfiram is superior to placebo. To evaluate whether dopamine-B-hydroxylase (DBH) genotypes associated with high, intermediate or low enzyme activity predict responses to disulfiram treatment of cocaine use in buprenorphine treated subjects. Study hypothesis 2 is that disulfiram efficacy is higher in subjects with low DBH compared to subjects with high DBH. To explore whether baseline measures of alcohol use predict response to disulfiram. Study Hypothesis 3 is that the effects of disulfiram on cocaine use are independent of the severity of baseline alcohol use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence, Opioid Dependency

Keywords

Disulfiram, Buprenorphine, Cocaine dependence, Opioid dependence, Dopamine-Beta-Hydroxylase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

177 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Disulfiram

Arm Type

Experimental

Arm Description

Disulfiram 250 mg per day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Disulfiram

Intervention Description

Disulfiram 250 mg per day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo daily

Primary Outcome Measure Information:

Title

Cocaine abstinence

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Opioid abstinence

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: English speaking adults ages 18 - 45. Meeting FDA criteria for agonist maintenance treatment and DSM-IV criteria for opioid dependence and cocaine dependence or abuse as assessed by SCID interview and documented by opioid positive and cocaine positive urine toxicology testing. Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy testing during the course of the study. Exclusion Criteria: Current physiologic dependence on benzodiazepines or alcohol, unless first detoxified. Subjects who use/abuse alcohol will be included but will be cautioned about alcohol use during the study because of the possibility of an alcohol-disulfiram reaction. Use of the antibiotic agents metronidazole or clotrimazole, which have disulfiram-like effects in combination with alcohol. Presence of significant cardiovascular, renal, hepatic or neurologic illness. Subjects with markedly abnormal liver function tests (i.e., AST of ALT > 3X normal) will also be excluded. Presence of any of the following cardiovascular risk factors: age > 45 years history of cocaine-related chest pain systolic blood pressure > 140 or diastolic blood pressure > 90 evidence of ischemia or past myocardial infarction on EKG significant family history of risk (first degree relative with myocardial infarction prior to age 60) elevated cholesterol (> 300 mg/dl), elevated LDL (> 170 mg/dl) or low HDL (< 20 mg/dl) Maintenance on methadone at doses greater than 30mg daily. Admittance to the study will only be offered to individuals who have been maintained on 30 mg of methadone or less daily for seven days prior to entering the study. Current suicide or homicide risk or current psychotic disorder. Inability to read or understand the symptom checklists.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard S. Schottenfeld, M.D.

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The APT Foundation MRU

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

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Disulfiram for Cocaine Abuse in Buprenorphine Treatment

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